HypErsensitiVity PneumonITis: DiseAse Progression Characterization

Recruiting

• Conditions: Hypersensitivity Pneumonitis
• Interventions: Other: Disease assessment

• Registration Number: NCT04961944
• Lead Sponsor: Hospital do Coracao

Brief Summary

EVITA is a multicentric Latin-American prospective cohort on chronic hypersensitivity pneumonitis. EVITA's objective is to identify phenotypes and/or endotypes associated with different disease trajectories measured primarily by forced vital capacity (FVC) during a 24 month follow-up period. Other secondary measures of disease progression will also be investigated such as imaging, time to death or lung transplantation, and patient-reported outcomes

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-14
• Study Start: 2022-06-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Adult outpatient subjects (18 years old or older) that fulfill the 2020 ATS/JRS/ALAT diagnostic criteria of HP of at least moderate confidence (70% confidence or more).
2. Willingness to undergo the evaluations proposed in this protocol
3. HP diagnosis within the last 24 months
4. Presence of radiological or histological fibrosis:

4.a. Radiological fibrosis consists of unequivocal fine or coarse reticulation with architectural lung distortion and/or traction bronchiectasis and/or honeycomb.

4.b. Unequivocal histopathological fibrosis evidenced on lung specimens

Exclusion Criteria

1. Pregnancy
2. Presence of established connective tissue disease
3. Severe comorbidity impacting on the respiratory system as judged by the attending physician (ex. congestive heart failure, neoplasm, post-COVID-19 sequelae)
4. Use of supplemental oxygen at rest
5. Dyspnea mMRC 4 (too breathless to leave the house or breathless when dressing or undressing)
6. Unequivocal emphysematous pattern of HP on HRCT
7. Unequivocal pleuro-parenchymal fibroelastosis on the HRCT
8. Significant pulmonary arterial hypertension:

8.a. Signs of right ventricular failure by echodopplercardiogram or 8.b. Cardiac index < 2L/min/m2 or right heart catheterism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypersensitivity pneumonitis	Disease assessment	see elegibility criteria

Primary Outcome Measures

Name	Time	Method
Variation in Forced Vital Capacity (FVC) as a continuous variable	24 months

Secondary Outcome Measures

Name	Time	Method
Time to death or lung transplantation	24 months
Variation in Computed Tomography Lung Densitometry	24 months
Acute exacerbation rate	24 months
King´s Brief Interstitial Lung Disease Questionnaire (K-BILD)	24 months

Trial Locations

Locations (10)

University Hospital HU Professor Polydoro - Federal University of Santa Catarina; 🇧🇷 Florianópolis, Brazil

Instituto Nacional del Tórax; 🇨🇱 Santiago, Chile

Hospital Prov de Tórax Dr. A. Cetrángolo; 🇦🇷 Bueno Aires, Argentina

Instituto de Rehabilitacion Psicofisica; 🇦🇷 Buenos Aires, Argentina

LABOX - Federal University of Santa Catarina; 🇧🇷 Santa Catarina, SC, Brazil

Hospital do Servidor Estadual de Sao Paulo (IAMPSE); 🇧🇷 Sao Paulo, Brazil

InCor - Medical School of the University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil

University of Buenos Aires; 🇦🇷 Buenos Aires, Argentina

LAPOGE - Federal University of Santa Catarina; 🇧🇷 Santa Catarina, SC, Brazil

Centro EDUMED; 🇧🇷 Paraná, Brazil